Stapling and Cutting in Resectioning for Full Thickness Resection Devices

ABSTRACT

A stapling unit for use with an endoscopic stapling system adapted to be advanced along an endoscope to a predetermined location within a body lumen to staple the portion of tissue, as part of an occlusal or full thickness resectioning procedure. The stapling unit comprises a first casing having a distal end, a proximal end and a stapling device mounted thereto adjacent to a first window extending through a periphery of the first casing. The invention includes methods for the stapling, severing and removal of tissue by using the device.

PRIORITY CLAIM

The present application is a Continuation of U.S. patent applicationSer. No. 12/029,639 filed on Feb. 12, 2008 which is a Continuation ofU.S. patent application Ser. No. 10/764,619, filed on Jan. 26, 2004 nowU.S. Pat. No. 7,334,718, which is a Continuation of U.S. patentapplication Ser. No. 10/083,097, filed on Feb. 26, 2002 now U.S. Pat.No. 6,716,222, which is a Continuation OF U.S. patent application Ser.No. 09/727,051 filed on Nov. 30, 2000 now U.S. Pat. No. 6,398,795, theentire disclosure of these applications are expressly incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to a device and method for staplingtissue, and more specifically, to grasping, stapling, and cutting tissuewithin a body lumen.

BACKGROUND INFORMATION

When tissue surrounding a body lumen becomes cancerous or otherwisediseased, it is often necessary to remove the diseased tissue foranalysis or disposal. Conventional devices and methods for such tissueremoval often require open surgery to access the diseased tissue.

In addition, endoluminal tissue cutters have been known, e.g., U.S. Pat.No. 5,947,983, issued to Solar et al. (“the Solar patent”), the entiredisclosure of which is expressly incorporated herein by reference. Manyof these devices relied on sutures to close the resulting wound.However, these devices have often been unwieldy as the manipulation ofsutures from outside the body can be extremely difficult.

SUMMARY OF THE INVENTION

The present invention is directed to a stapling unit for use with anendoscopic stapling system comprising a first casing adapted to beadvanced along an endoscope to a predetermined location within a bodylumen, the first casing having a distal end, a proximal end and astapling device mounted thereto adjacent to a first window extendingthrough a periphery of the first casing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D illustrate a first embodiment of a device according to thepresent invention.

FIG. 1A illustrates a first view of a first embodiment of a deviceaccording to the present invention.

FIG. 1B illustrates a second view of the first embodiment of FIG. 1A.

FIG. 1C illustrates a third view of the first embodiment of FIG. 1A.

FIG. 1D illustrates a fourth view of the first embodiment of FIG. 1A.

FIG. 2A illustrates a configuration of the first embodiment of FIG. 1A,wherein the components move rotationally with respect to each other.

FIG. 2B illustrates a configuration of a second embodiment of thepresent invention, wherein the components move longitudinally withrespect to each other.

FIGS. 3A-3C illustrate movement of a stapling device according to thepresent invention from a stapler retracted position to a stapler engagedposition.

FIG. 3A illustrates the stapling device according to the presentinvention in a stapler retracted position.

FIG. 3B illustrates the stapling device of FIG. 3A in a stapler engagedposition.

FIG. 3C illustrates the stapling device of FIGS. 3A and 3B in a staplerengaged position.

FIG. 4 illustrates a third embodiment of a device according to thepresent invention.

FIGS. 5A-5B illustrates a fourth embodiment of a device according to thepresent invention.

FIG. 5A illustrates a first view of the fourth embodiment of a deviceaccording to the present invention.

FIG. 5B illustrates a second view of the fourth embodiment of FIG. 5A.

FIG. 6A illustrates a configuration of the fourth embodiment of FIG. 5A,wherein the components move rotationally with respect to each other.

FIG. 6B illustrates a configuration of a fifth embodiment of the presentinvention, wherein the components move longitudinally with respect toeach other.

FIGS. 7A-7C illustrate movement of the tissue cutter in the fourthembodiment of FIG. 5A according to the present invention from a cutterengaged position to a cutter complete position.

FIG. 7A illustrates the tissue cutter of FIG. 5A in a cutter retractedposition.

FIG. 7B illustrates the tissue cutter of FIG. 5A in a cutter engagedposition.

FIG. 7C illustrates the tissue cutter of FIG. 5A in a cutter completeposition.

FIG. 8 illustrates a sixth embodiment of a device according to thepresent invention.

FIG. 9 illustrates a seventh embodiment of a device according to thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides for the stapling and removal of tissuewithin a body lumen without resorting to open surgery and allows for theidentification of tissue desired for stapling and removal from a bodylumen. The device makes possible accurate, localized in-situ stapling oftissue and the severing of tissue below the staple line. A fullthickness portion of a body lumen wall can be extracted quickly andsimply minimizing and/or eliminating bleeding or leakage from the lumen.

FIGS. 1A-1D show a device according to the present invention. As shownin FIGS. 1A and 1B, the stapling unit 1 is part of an endoscopicstapling system 200, which comprises an endoscope 3, a control unit 8,and a shaft 210. The endoscope 3 for use with the current invention maypreferably be a gastroscope or end-viewing endoscope 2 for real-timeviewing of an interior 5 of a body lumen 4. The stapling unit 1 may bepositioned adjacent to a portion of tissue to be stapled 7 by firstinsufflating the body lumen 4 and locating the portion of tissue visiblyusing the endoscope 3. The stapling unit may then be advanced distallyalong the endoscope 3 to a desired position relative to the portion oftissue 7. The stapling unit 1 can be operated remotely via a controlunit 8 located outside the body during use.

FIG. 1B details the stapling unit 1 in one embodiment which can be used,for example, in an occlusal procedure. The stapling unit 1 comprises afirst casing 10, which may, for example, be formed as a partiallytubular member 11. The stapling unit 1 has a window 20 formed in adistal portion 15 thereof exposing an interior 16 of the stapling unit 1to an exterior 17 of the stapling unit 1. A stapling device 50 ismounted to the unit 1 adjacent to the window 20. If an endviewingendoscope 2 is used to find the location of the portion of tissue to bestapled 7 and kept at the location after the stapling unit 1 has beenpositioned there, an operator can continuously view the work done on theportion of tissue 7 by looking through the window 20 from an interior ofthe stapling unit 1 to an interior 5 of the body lumen 4. FIGS. 1C and1D detail each component of the stapling unit 1. The window 20optionally has a fixed perimeter and shape, which may, for example berectangular. One edge 26 of the window 20 may form an anvil 12. Thestapling device 50 may have a movable staple head 52, forming a staplefiring edge 54, which, when the stapling device 50 is mounted in thefirst casing 10, faces the anvil 12.

The orientation and movement of the components in the first embodimentis shown in FIG. 2A. The stapling head 52 may be rotatably mountedwithin the first casing 10 so that, in a first position, the staplefiring edge 54 is adjacent to the anvil 12. The stapling unit 1 mayrotate, for example, about an axis substantially parallel to alongitudinal axis 14 of the first casing 10. Then, the staple head 52 isrotated relative to the first casing 10, to a second position.

An alternative orientation and movement of the components is shown in asecond embodiment of a device according to the present invention, shownin FIG. 2B. In the second embodiment, the stapling head 52′ may bemovably mounted in a longitudinal direction within the first casing 10′so that, in a first position, the staple firing edge 54′ is adjacent tothe anvil 12′. The stapling unit 1′ may move longitudinally, forexample, parallel to an axis substantially parallel to a longitudinalaxis 14′ of the first casing 10′. Then, the stapling head 52′ is movedlongitudinally relative to the first casing 10′, to a second position.

Returning to the orientation and movement of the components in the firstembodiment of the device according to the present invention, as detailedin FIGS. 3A-3C, the stapling device 50 can be mounted so that the staplehead 52 covers a portion 24 of the window 20, while being movablycoupled to the first casing 10. The size of the portion 24 of window 20covered varies depending on whether the staple head 52 has been movedrelative to the first casing 10 between a stapler retracted position(detailed in FIG. 3A) and a stapler engaged position (detailed in FIGS.3B and 3C). When the staple head 52 is in the stapler retractedposition, the staple head 52 covers a smaller portion 22 of window 20 toprovide space for drawing the portion of tissue to be stapled 7 into thewindow 20. When the staple head 52 is moved to the stapling position,the staple head 52 covers a larger portion 23 of the window 20 so that aportion of tissue 7 received in the window 20 is grasped between thestaple firing edge 54 and the anvil 12.

As shown in FIG. 3B, the distance between the staple firing edge 54 andthe anvil 12 when the staple head 52 is in the stapling position is apredetermined stapling distance or thickness 63. The stapling device 50may optionally have a position adjusting mechanism 27 (shown in FIG.1A), operated using the control unit 8, to adjust this predeterminedstapling distance 63 before firing staples (not shown) from the staplefiring edge 54, through the tissue 7 and against the anvil 12. Thestapling unit 1 can have a stapling actuating mechanism 28 (shown inFIG. 1B), also operated using the control unit 8 and coupled between thestapling device 50 and a proximal end 19 of the unit 1 to activate thestaple head 52 to fire staples (not shown) from the staple firing edge54, through the tissue 7, and against the anvil 12 to staple the portionof tissue 7 grasped between the staple firing edge 54 and the anvil 12.

A third embodiment of a device according to the present invention shownin FIG. 4 is similar to the first embodiment except that in the thirdembodiment, the stapling device 50″ may be mounted onto a second casing70. The second casing 70, may, for example, be partially tubular member71, which also has a window 80 formed in a distal portion thereof. Thewindow 80 faces the window 20″ of the first casing 10″ when the secondcasing 70 and first casing 10″ are in a predetermined alignment withrespect to one another to form an opening from an interior 16″ of thestapling unit 1″ to an exterior 17″ of the stapling unit 1″. The staplefiring edge 54″ is positioned on an edge 84 of the window 80 and facingthe anvil 12″ which is formed on an opposing edge 26″ of the window 20″so that moving the staple head 52″ from the stapler retracted positionto the stapling position translates into moving the distal portion 75 ofthe second casing 70, changing the predetermined alignment of thewindows 20″ and 80 so that the staple firing edge 54″ is moved towardsthe anvil 12″ in direction 77.

A fourth embodiment of a device according to the present invention shownin FIGS. 5A and 5B is similar to the first embodiment except that in thefourth embodiment, the stapling unit 1′″ may also have a tissue cutter90. The tissue cutter 90 enables the stapling unit 1′ to be used, forexample, for full thickness resectioning procedures during which aportion of tissue below the staple line is severed and removed from thebody lumen 4 for testing.

The orientation and movement of the components in the fourth embodimentis shown in FIG. 6A. The cutting edge 94 may be rotatably mounted withinthe first casing 10′″ so that, in a first position, the cutting edge 94is adjacent to a side 25 of the window 20′″ which is substantiallyparallel to a longitudinal axis 14′″ of the first casing 10′″. Thetissue cutter 90 may rotate, for example, about an axis substantiallyparallel to a longitudinal axis 14′″ of the first casing 10′″. Then, thecutting edge 94 is rotated relative to the first casing 10′″ to cut theissue grasped between the staple device 50′″ and the anvil 12′″.

An alternative orientation and movement of the components is shown in afifth embodiment of a device according to the present invention, shownin FIG. 6B. In the fifth embodiment, the tissue cutter 90″″ is movablymounted in a longitudinal direction within the first casing 10″″ sothat, in a first position, the cutting edge 94″ is adjacent to a side25″″ of the window 20″″ which is substantially parallel to acircumference 18″ of the first casing 10″″. When the tissue cutter 90″″is moved axially relative to the first casing 10″″ and stapling device50″″ along the longitudinal axis 14″″ of the first casing 10″″ thecutting edge 94″ severs the tissue grasped by the staple device and theanvil.

Returning to the orientation and movement of the components in thefourth embodiment of the device according to the present invention, asdetailed in FIGS. 7A-7C, the tissue cutter 90 is movably mounted to thestapling device 50′″ and the first casing 10′″ adjacent to the window20′″. The tissue cutter 90 is movable between a retracted position(shown in FIG. 7A), where the tissue cutter 90 is withdrawn from thewindow 20′″, and a tissue cutting position (shown in FIG. 7B), where thetissue cutter 90 is engaged with a portion of tissue 9 to be severed.The tissue cutter 90 has a cutting edge 94 which is angled such that afirst portion 97 of the cutting edge 94 contacts the portion of tissue 9to be severed before a second portion 98 of the cutting edge 94, i.e.,the cutting edge 94 is preferably formed as an angled blade.

Once a portion of tissue has been severed, the tissue cutter 90 is movedto a cutter complete position (detailed in FIG. 7C), covering the firstwindow 20′″ completely and containing the severed portion of tissuewithin the first casing 10′″. Once contained, the stapling unit 1′″ isremoved from the body lumen 4′″ and opened to retrieve the severedportion of tissue for possible testing. The tissue cutter 90 accordingto the present invention enables an operator to remove a clean tissuesample from a body lumen.

Movement of the tissue cutter 90 may be controlled by a cutting actuatormechanism 99 (shown in FIG. 1A) coupled between a proximal end 19 of theunit 1 and the tissue cutter 90, and operated remotely via the controlunit 8. The tissue cutter 90 also preferably has a safety mechanismwhich prevents the operator from engaging the tissue cutter 90 untilafter the operator determines that all the staples have been properlyfired.

A sixth embodiment of a device according to the present invention shownin FIG. 8 is similar to the fourth embodiment except that in the sixthembodiment, the tissue cutter 90′ may be mounted on a third casing 110.The third casing 110 may, for example, be a partially tubular member111, which also has a window 120 formed in the distal portion 115thereof. The window 120 faces the window 20′″″ of the first casing 10′″″when the third casing 110, the stapling device 50′″″ and first casing10′″″ are in a predetermined alignment with respect to one another toform an opening from an interior 16′″″ of the stapling unit 1′″″ to anexterior 17′″″ of the stapling unit 1′″″. The cutting edge 94′″″ ispositioned adjacent to an edge 124 of the window 120, and the cuttingedge 94′″″ preferably may still be angled as shown in FIGS. 5A and 7B,so that a first portion 97′″″ of the cutting edge 94″ contacts thetissue to be cut before a second portion 98′″″ of the cutting edge94′″″. Rotational movement of the tissue cutter 90′″″ from the retractedposition to the tissue cutting position translates into rotationalmovement of the distal portion 115 of the third casing 110, changing thepredetermined alignment of the windows 20′″″ and 120 so that the cuttingedge 94′″″ is moved towards the opposing edge 21′″″ of the window 20′″″on the first casing 10′″″ in direction 117.

In a seventh embodiment detailed in FIG. 9, the stapling unit 1″″″operates similarly as described above, but is comprised of threeconcentric tubes 11″″″, 71″″″ and 111″″″ with windows 20′″″, 80″″″, and120″″″ which form an opening 124″″″ from an interior 16″″″ of thestapling unit 1″″″ to an exterior 17″″″ of the stapling unit 1. One edge26″″″ of the window 20″″″ on the first tube 11″″″ forms an anvil 12″″″.The stapling device 50″″″ is mounted to second tube 71″″″ which ismovably mounted within the first tube 11″″″, and an edge 84″″″ on thewindow 80″″″ on the second tube 71″″″ forms a staple firing edge 54″″″which faces the anvil 12″″″. The tissue cutter 90 i″″″s mounted to thethird tube 111″″″ which is movably mounted within the second tube 71″″″and the first tube 111″″″, and an edge 124″″″ of the window 120″″″ onthe third tube 111″″″ forms the cutting edge 94″″″.

Any of the embodiments of the present invention may optionally include atissue grasper 60 (detailed in FIG. 1B) within the stapling unit 1, todraw the portion of tissue 7 to be stapled and the portion of tissue tobe cut into the window 20 to an interior 16 of the stapling unit 1 whenthe stapling device 50 and tissue cutter 90 are withdrawn to retractedpositions. As known in the art, the tissue grasper 60 grabs the portionof tissue 7 with, for example, a pair of jaws 61, while a vacuum tube(not shown) sucks tissue 7 through the window 20 by creating negativepressure within the window 20. Alternatively, suction may be appliedthrough the device to draw the portion of tissue 7 to be stapled and theportion of tissue 9 to be cut into the window 20 to an interior 16 ofthe stapling unit 1.

The present invention provides a device and method for theminimally-invasive grasping, stapling and removal of diseased tissuefrom within a body lumen. Those with skill in the art may recognizevarious modifications to the embodiments of the invention described andillustrated herein. Such modifications are meant to be covered by thespirit and scope of the appended claims.

1.-56. (canceled)
 57. A stapling unit for an endolumenal staplingsystem, comprising: a housing including a substantially tubular wall,the tubular wall including a window extending therethrough with an anvilformed on a first edge of the window, the housing further including astapling apparatus for movement between a stapling position in which astaple firing surface of the stapling apparatus is adjacent to theanvil, the staple firing surface housing a staple therewithin, and atissue receiving position in which the staple firing surface isseparated from the anvil to expose a tissue receiving cavity within aninterior of the housing, the staple firing apparatus being configured todrive the staple out of the staple firing surface and through tissuehaving at least a portion drawn into the tissue receiving cavity; and atissue grasping mechanism extendible through the window for drawingtissue through the window into the tissue receiving cavity.
 58. Thestapling unit according to claim 57, wherein the stapling apparatus ismounted within the housing for rotation about a longitudinal axis of thehousing between the stapling and tissue receiving positions.
 59. Thestapling unit according to claim 57, wherein the stapling apparatus ismounted within the housing for motion substantially parallel to alongitudinal axis of the housing.
 60. The stapling unit according toclaim 57, further comprising: a tissue cutting mechanism mounted withinthe housing for cutting tissue located radially within a portion oftissue stapled by the stapling apparatus.
 61. The stapling unitaccording to claim 60, wherein the tissue cutting mechanism includes apartially cylindrical member rotatably mounted within the housingradially within the stapling apparatus and including an angled tissuecutting surface.
 62. The stapling unit according to claim 60, whereinthe tissue cutting mechanism includes a partially cylindrical membermounted within the housing radially within the stapling apparatus andbeing configured to move along one of a longitudinal axis and an axisextending orthogonally to the longitudinal axis of the housing.
 63. Thestapling unit according to claim 57, wherein the stapling apparatus ismounted within the housing to rotate about an axis thereof across thewindow.
 64. The stapling unit according to claim 57, wherein thestapling apparatus is mounted within the housing to move along an axisthereof across the window.
 65. The stapling unit according to claim 57,wherein the stapling apparatus is mounted within the housing to movetransversely to an axis thereof across the window.
 66. The stapling unitaccording to claim 57, wherein the anvil extends from an outer surfaceof the housing and into the tissue receiving cavity by depth selected topermit engagement with the staple firing surface.
 67. The stapling unitaccording to claim 57, wherein the staple firing surface extendssubstantially parallel to a longitudinal axis of the housing.
 68. Thestapling unit according to claim 57, wherein the staple firing surfaceextends substantially orthogonally to a longitudinal axis of thehousing.
 69. A stapling unit for use with an endoscopic stapling system,comprising: a first casing adapted to be coupled to an endoscope forplacement within a body lumen, the first casing having a distal end, aproximal end, a tissue cutter being mounted to the first casing adjacentto a first window extending through a periphery of the first casing; anda stapling device mounted to the first casing adjacent to the firstwindow, the stapling device having a staple firing surface housing astaple therewithin.
 70. The stapling unit of claim 69, wherein thetissue cutter is movably mounted to the first casing adjacent to thefirst window for movement between a retracted position and a tissuecutting position.
 71. The stapling unit of claim 69, wherein the tissuecutter is moved relative to the first window along a longitudinal axisof the first casing.
 72. The stapling unit of claim 69, wherein thetissue cutter is rotated relative to the first window.